Corning Incorporated (NYSE: GLW) and Medichem S.A. have successfully demonstrated a commercial scale continuous-flow production of active pharmaceutical ingredients (APIs) using the Corning® Advanced-Flow™ G4 silicon carbide reactor.
Medichem was able to produce an organometallic compound API under cGMP conditions in several production campaigns and can now repeat its results with a continuous flow multipurpose unit at industrial scale. Corning provided a turnkey equipment solution including automated feeding systems that comply with the ATEX directive and G4 reactor.
"Our innovative technology has made robust, industrial, continuous-flow production a successful part of Medichem’s manufacturing operation," said Dr. Yi Jiang, global business director for Corning Reactor Technologies . "Our reactors’ patented heart-shaped design and engineering expertise provided Medichem with a customized reactor solution to help them achieve a smaller footprint and a short return on investment. We look forward to continuing our excellent collaboration with Medichem."
Medichem switched to flow reactor technologies after conventional equipment presented challenges. Medichem’s proper flow devices along with Corning’s continuous flow reactors achieved such encouraging results that Medichem decided to evaluate scaling-up by integrating a Corning® Advanced-Flow™ G1 reactor . Consistent quality and reliable performance properties led them to implement the same process with a Corning® Advanced-Flow™ G4 reactor at plant scale. This resulted in seamless scale-up in both yields and industrial purity, thus accomplishing the main challenge of this application.
Medichem was concerned with an organometallic process that reduced the yield dramatically every time they scaled up. After some testing with continuous flow, they were able to reproduce and scale up with the same yield and even better purity than their conventional batch process.
Corning reactors enable optimized cost of manufacturing high-quality chemicals for the specialty, fine, and pharmaceutical industries. Compared to batch reactors, Corning® Advanced-Flow™ reactors can enable 100 times enhancement in mixing, 1,000 times improvement in heat transfer performance, and seamless and efficient scale-up from the lab to full-scale production. Corning's proprietary reactor technology is compact, adaptable, and seamlessly scalable. Corning is working with key customers around the world to develop various flow reactors that optimize chemical processing results. Economic concerns, environmental impact, and regulatory authorities are helping to make continuous-flow reactors more mainstream.
Forward-Looking and Cautionary Statements
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About Corning Incorporated
Corning (www.corning.com) is one of the world's leading innovators in materials science. For more than 160 years, Corning has applied its unparalleled expertise in specialty glass, ceramics, and optical physics to develop products that have created new industries and transformed people's lives. Corning succeeds through sustained investment in R&D, a unique combination of material and process innovation, and close collaboration with customers to solve tough technology challenges. Corning's businesses and markets are constantly evolving. Today, Corning's products enable diverse industries such as consumer electronics, telecommunications, transportation, and life sciences. They include damage-resistant cover glass for smartphones and tablets; precision glass for advanced displays; optical fiber, wireless technologies, and connectivity solutions for high-speed communications networks; trusted products that accelerate drug discovery and manufacturing; and emissions-control products for cars, trucks, and off-road vehicles.
Medichem ( www.medichem.es ) is an independently-owned API manufacturer, headquartered in Barcelona (Spain) with more than 40 years of experience in this market. Medichem has two FDA inspected plants (Spain and Malta) and 3 R&D centers located in Spain, Malta and China. The company has more than 250 people working at various locations (Spain, Malta and China) and delivers products to more than 60 countries (United States, the European Union and Japan among others). Medichem is recognized for its broad pipeline of new products indicated for the treatment of diseases in many therapeutic areas, such as Central Nervous System, Cardiovascular, Gastrointestinal, Ophthalmic, etc... Medichem has a sister company, Combino Pharm, which manufactures, develops and markets generic pharmaceutical products. Both companies offer Contract Manufacturing services (regular and Highly Potent APIs and FDF).